Study: Toxic Shock Syndrome Vaccine Safe

Researchers have developed the first vaccine against toxic shock syndrome (TSS), a potentially life-threatening disease for which no treatment or preventive measures are currently available. 

To test the safety and efficacy of the recombinant detoxified toxic shock syndrome toxin-1 variant vaccine (rTSST-1v), researchers conducted a randomized, double-blind, adjuvant-controlled, dose-escalation first-in-human trial involving healthy adults aged 18 to 64 who were randomly assigned to receive either increasing doses of the TSS vaccine or the adjuvant comparator aluminum hydroxide (Al[OH]3). Booster immunization was given 42 days after the first vaccination. The primary endpoint of the study was safety and tolerability of the vaccine.
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The 46 participants were randomly assigned to cohorts in the following way:

  • 3 assigned to cohort 1 (2 to receive 100 ng rTSST-1v and 1 to receive 200 μg Al[OH]3)
  • 3 assigned to cohort 2 (2 to receive 300 ng rTSST-1v and 1 to receive 600 μg Al[OH]3)
  • 4 assigned to cohort 3 (3 to receive 1 μg rTSST-1v and 1 to receive 1 mg Al[OH]3)
  • 12 assigned to cohort 4 (9 to receive 3 μg rTSST-1v and 3 to receive 1 mg Al[OH]3)
  • 12 assigned to cohort 5 (9 to receive 10 μg rTSST-1v and 3 to receive 1 mg Al[OH]3)
  • 12 assigned to cohort 6 (9 to receive 300 μg rTSST-1v and 3 to receive 1 mg Al[OH]3)

Overall, no vaccination-related severe or serious adverse events were reported. Adverse event rates were similar between patients receiving the vaccine and placebo (76% vs 83%).

“rTSST-1v was safe, well-tolerated, and immunogenic. This study represents an important step in vaccine development to prevent or treat a potentially lethal disease,” the researchers concluded.

The researchers further reported that a new phase 2 trial with a larger test population has now begun to further evaluate and confirm the results seen in this initial study.

—Michael Potts

Reference:

Schwameis M, Roppenser B, Firbas C, et al. Safety, tolerability, and immunogenicity of a recombinant toxic shock syndrome toxin (rTSST)-1 variant vaccine: a randomised, double-blind, adjuvant-controlled, dose escalation first-in-man trial [published online June 10, 2016]. Lancet Infec Dis. doi: http://dx.doi.org/10.1016/S1473-3099(16)30115-3.